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510(k) Data Aggregation

    K Number
    K130788
    Device Name
    CAPELLA
    Manufacturer
    FUTURE MOBILITY HEALTHCARE INC.
    Date Cleared
    2013-12-05

    (258 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUTURE MOBILITY HEALTHCARE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Future Mobility Healthcare Inc. Capella wheelchair is intended to provide mobility to persons limited to a sitting position.
    Device Description
    Dynamic tilt in space mechanical wheelchair which offers adjustability to redistribute the body weight for optimal positioning. The tilting is operated by the care-giver in the back handles of the chair. The Capella/Capella 45 can accommodate different size occupants. The seat width and depth can be ordered in several sizes. The Capella/Capella 45 is constructed of a rigid, aluminum frame with anti-tippers and the ability to tilt and manual recline. Depending on the seat depths, it has a capacity to support a human weight of 350lbs (250lbs Capella45). One gas spring is used to lift an ddecline the seat and back to the tilting positions in the Capella 45. And the Capella uses two gas springs. The gas spring(s) are connected by cables to levers on the push bar so that they can be locked and unlocked by the caregiver.
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    K Number
    K103073
    Device Name
    SUPER CHAIR FOR KIDS BY ORION
    Manufacturer
    FUTURE MOBILITY HEALTHCARE INC.
    Date Cleared
    2011-01-03

    (77 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUTURE MOBILITY HEALTHCARE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Future Mobility Healthcare Inc. Super Chair for Kids by Orion Wheelchair is intended to provide mobility to persons limited to a sitting position.
    Device Description
    The ORIONII, Zippie TS and Super Chair for Kids by Orion tilt in space wheelchairs are manually operated, self propelled mechanical wheelchairs, and may also be used as attendant propelled transport devices. They consist of mechanical steel frames for use by patients weighing up to 150 lbs.
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    K Number
    K102031
    Device Name
    GALAXY LITE
    Manufacturer
    FUTURE MOBILITY HEALTHCARE INC.
    Date Cleared
    2010-10-20

    (93 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUTURE MOBILITY HEALTHCARE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Future Mobility Healthcare Inc. Galaxy Lite Wheelchair is intended to provide mobility to persons limited to a sitting position.
    Device Description
    The Quickie 2 HP, Stellato and Galaxy Lite folding wheelchairs are manually operated, self propelled mechanical wheelchairs, and may also be used as attendant propelled transport devices. They consist of folding mechanical aluminum frames for use by patients weighing up to 250 lbs.
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    K Number
    K101277
    Device Name
    ORION II (HEAVY DUTY 350 LBS AND 500 LBS)
    Manufacturer
    FUTURE MOBILITY HEALTHCARE INC.
    Date Cleared
    2010-06-04

    (29 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUTURE MOBILITY HEALTHCARE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide mobility to persons limited to a sitting position.
    Device Description
    The ORION II Medical device and the Orion (Heavy Duty 350lbs and 500lbs) are mechanical wheelchairs which have technical similarities such as a tilt, and recline capabilities. Both devices contain an adjustable back angle and provide similar performance. The modifications consist of wider frames with a reinforced design to withstand the higher weight capacities of 350lbs and 500lbs. This modification is intended to allow the weight capacity of the wheelchair to increase from 250lbs to 350lbs for the additional widths ranging from 21" to 24", and to 500lbs for additional widths ranging from 24" to 32".
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    K Number
    K061010
    Device Name
    FUTURE MOBILITY HEALTHCARE INC. ORION II WHEELCHAIR AND STELLATO MECHANICAL WHEELCHAIR
    Manufacturer
    FUTURE MOBILITY HEALTHCARE INC.
    Date Cleared
    2006-05-23

    (41 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUTURE MOBILITY HEALTHCARE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Future Mobility HealthCare Inc. Orion II Wheelchair is intended to provide mobility to persons limited to a sitting position.
    Device Description
    The Future Mobility HealthCare Orion II wheelchair is a compact tilt-in-space wheelchair offering 45° of tilt, 30° of recline and adjustable seat-to-floor heights of 12 3/4' to 19". It consists of rigid, mechanical, steel frame and upholstery that meets the California Technical Bulletin CAL 117 standard for flame retardant. It has two rear wheels (12", 20", 22" or 24" in diameter) and two front casters (4", 5", 7" or 8" in diameter) for turning and maneuverability.
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